The Natural History of Congenital Trigger Thumbs

NCT01424995 | Completed

• 1 other identifier: 32047
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective study of all children ages 0 - 5 years old at the time of entry into the study that meet the inclusion criteria who present with congenital trigger thumb. Patient records will be reviewed for eligibility before obtaining parental permission. They will be enrolled in the study at their first visit and followed every year for up to 4 years or until one of the exclusion criteria are met. Participating sites include the University of Utah Orthopaedic Center, Primary Children's Medical Center and Shriners Hospital for Children.

Conditions

Congenital Trigger Thumb; Tenosynovitis

Keywords

trigger thumb; flexor pollicis longus tendon of the thumb; stenosis tenosynovitis

Outcome Measures

Primary Outcomes (1)

• The goal of this study is to prospectively evaluate the natural history of congenital trigger thumbs to determine the true incidence of spontaneous resolution.

  The following physical exam measurements will be made at the first visit and all subsequent visits until completion of the study: flexion contracture of the interphalangeal joint of both thumbs (resolution of deformity defined as when flexion contracture is 0°), metacarpal-phalangeal joint laxity, and amount interphalangeal joint angular deformity.

  4 years

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study will evaluate all patients who present to our institution with congenital trigger thumb over a one year period and choose not to have a surgical intervention

You may qualify if:

• Diagnosis of congenital trigger thumb based on physical exam and history, no previous treatment history (either operative or non-operative), no pain associated with the deformity, no functional disability due to the trigger thumb.

You may not qualify if:

• Previous operative treatment for the congenital trigger thumb, deformity of the thumb that causes pain, triggering that causes secondary deformity of the thumb, and deformity that prevents normal use of the thumb and hand.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Univeristy of Utah Orthopedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Recurrent trigger thumb; Tenosynovitis; Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Tendon Entrapment

Study Officials

• Douglas T Hutchinson, MD

  University of Utah Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: August 29, 2011
• Study Start: December 1, 2010
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

US (1)